Pneumococcal Vaccination of Otitis-prone Children

Not Applicable

Completed

• Conditions: Recurrent Acute Otitis Media
• Interventions: Biological: Prevenar

• Registration Number: NCT01263210
• Lead Sponsor: Lund University Hospital

Brief Summary

Acute otitis media (AOM) is a common childhood disease, which becomes recurrent in 15-20% of the cases. Streptococcus pneumoniae is one of the leading causative agents, and a small reduction in the number of AOM episodes has been noted in unselected child cohorts after vaccination with conjugate heptavalent pneumococcal vaccine. This study was performed in order to investigate whether vaccination could reduce the number of AOM episodes in very young, otitis-prone children.

Detailed Description

Ninetysix children (46 vaccinated, 50 not) with an onset of AOM before six months of age, implying a high risk for developing rAOM, were recruited between 2003 and 2007. They were closely followed with clinical visits and nasopharyngeal cultures until the age of two years.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2009-06
• Study Completion: 2010-06
• Status Verified: 2010-12
• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-17
• Last Update Submitted: 2010-12-17
• Study First Posted: 2010-12-20
• Last Update Posted: 2010-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

First episode of acute otitis media before 6 months of age and verified by an otorhinolaryngologist.

Exclusion Criteria

Allergy to the vaccine, anatomical abnormality (eg cleft palate), chromosomal abnormality, immune deficiency, prematurity, prior administration of gammaglobulin or pneumococcal vaccine and a history of idiopathic thrombocytopenic purpura.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumococcal vaccine	Prevenar	Half of the children were randomized to receive heptavalent pneumococcal conjugate vaccine (before this vaccine was included in the national immunization programme).

Primary Outcome Measures

Name	Time	Method
Possible reduction of the number of acute otitis media episodes after conjugate pneumococcal vaccination in young otitis-prone children	2 years	Children with an acute otitis media onset before 6 months of age, implying an 80% risk for developing recurrent acute otitis media, were allocated to vaccination with heptavalent conjugate pneumococcal vaccine or to no vaccination. The number of acute otitis media episodes before two years of age in each group were recorded.

Secondary Outcome Measures

Name	Time	Method
Nasopharyngeal carriage in young otitis-prone children	3 years	The children in the vaccination study described above, had nasopharyngeal samples taken very frequently (every other month during the first year in the study, and at every suspected new episode of acute otitis media). The cultures were analyzed and compared with respect to vaccination status, risk factors, proneness to acute otitis media etc

Trial Locations

Locations (1)

ENT Department, Lund University Hospital; 🇸🇪 Lund, Sweden